Flotufolastat F 18 PET in Men With Very Low PSA Recurrence
NCT ID: NCT06862856
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-05-20
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Very Low Prostate Specific Antigen Recurrence
Men \>18 years of age will undergo screening to confirm eligibility for this research study. Participants will receive a PET scan with flotufolastat F 18 injection on study visit 2.
Positron Emission Tomography (PET)
This is a PET scan with flotufolastat F 18 injection.
Interventions
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Positron Emission Tomography (PET)
This is a PET scan with flotufolastat F 18 injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
* At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
* Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
* Age ≥18 years.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
* Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \<24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
18 Years
MALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Blue Earth Diagnostics
INDUSTRY
Responsible Party
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Jason Efstathiou
Principal Investigator
Principal Investigators
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Jason Efstathiou, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Jason Efstathiou, MD, DPhil
Role: primary
Jonathan Leeman, MD
Role: primary
Other Identifiers
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24-770
Identifier Type: -
Identifier Source: org_study_id